Last synced on 30 May 2025 at 11:05 pm

TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K011045
510(k) Type
Traditional
Applicant
SHEN WEI (USA), INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/11/2001
Days to Decision
159 days
Submission Type
Statement

TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K011045
510(k) Type
Traditional
Applicant
SHEN WEI (USA), INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/11/2001
Days to Decision
159 days
Submission Type
Statement